Unlawful use of fake Botox leads to health issues for unsuspecting patients, prompting MHRA to tighten regulations

The Medicines and Healthcare products Regulatory Agency (MHRA) is taking action against the illicit trade in unlicensed botulinum toxin products, commonly used in cosmetic procedures.

Anyone caught selling or supplying these unlicensed products faces up to two years in prison and unlimited fines under the Human Medicines Regulations 2012. The illegal trade is being carried out by sellers and practitioners, often untrained, who offer injections in unsafe, unregulated settings.

Legitimate treatments should only be carried out by qualified healthcare professionals in proper clinical settings with appropriate emergency equipment available. However, the treatments are being delivered in informal settings such as domestic bedrooms and kitchens, hair salons, and through mobile beauty services.

Members of the public are often lured in by adverts on social media promising quick, cheap results. But Health Minister Stephen Kinnock has stated that the government is determined to crack down on cosmetic cowboys who offer cut-price treatments outside suitable medical settings.

The MHRA's Criminal Enforcement Unit has launched criminal investigations following a spike in hospital admissions believed to be linked to the use of unlicensed botulinum toxin products. Since May 2023, the Unit has seized more than 4,700 vials of these products, with almost all of the seized products originating in South Korea.

The manufacturer with the most illegal botulinum toxin products originating from South Korea, seized in the UK between May 2023 and August 2025, is Meditoxin.

Unlicensed botulinum toxin products can have life-threatening consequences for those who use them. Symptoms of botulism caused by botulinum toxin in cosmetic procedures are rare, but can include difficulty swallowing, slurred speech, and breathing difficulty. Anyone who has recently received a botulinum toxin treatment and develops any of these symptoms should seek medical help immediately.

Before any treatment, verify that your practitioner is medically qualified and registered with their professional body. Check that products being used are licensed in the UK by asking to see packaging and checking batch numbers. Anyone who experiences side effects or complications after a cosmetic procedure can report them via the Yellow Card scheme at https://yellowcard.mhra.gov.uk/.

MHRA Chief Safety Officer Dr Alison Cave emphasized that buying botulinum toxin in any circumstances other than those prescribed by a doctor or other qualified healthcare professional significantly increases the risk of getting a falsified or unlicensed product. Lower cost does not mean safe; it may put your health at risk and could lead to hospitalization.

Suspicious signs include unusually cheap prices, treatments offered in domestic settings, or practitioners who cannot provide proper credentials. The MHRA is using the full force of the law against those who supply unlicensed medicines, including unlicensed botulinum toxin.

The agency urges the public to be vigilant and to only seek cosmetic treatments from qualified healthcare professionals in proper clinical settings. Licensed botulinum toxin products undergo rigorous testing and quality controls to ensure they contain the correct active ingredient at safe concentrations.

Unlawful use of fake Botox leads to health issues for unsuspecting patients, prompting MHRA to tighten regulations